The present disclosure relates to a cuff of balloon for an endotracheal tube for use with pediatric patients.
In the medical community it is well known that children are not merely small adults. Drugs, for example, may have no effect or the opposite effect on a child while being highly effective for an adult. Likewise, pediatric anatomy is quite different from that of adults. The distance from the vocal cords to the mouth is different than that of adults and the tissues of the throat, fragile and sensitive as they are in adults, are even more so in children.
Conventional tracheal tubes typically have a tube that serves as an artificial passage for the exchange of air between a patient and an air source, typically either atmospheric air or a mechanical respirator or ventilator. The distal end of the tube is usually equipped with a small, inflatable balloon, also called a cuff, which can be filled with a fluid (e.g., air). The balloon adheres to the internal lining of the trachea in its generally cross-sectional dimension in order to prevent air insufflated by the respirator into a patient from escaping to the environment through the larynx and pharynx. This enables the air to reach the lower airways and eventually the pulmonary alveoli. The balloon also aids in supporting the tube inside the trachea.
Pediatric tracheal tubes without sealing cuff balloons are available but are disadvantageous for ventilation in many cases, however. Surgery is especially problematic, requiring very constant maintenance of anesthesia (stable ventilatory minute volume) and constant blood gas levels, as is potentially the case, for example, with cardiac or neurosurgical intraoperative ventilation. During intensive care ventilation, spontaneous changes in the position of the child can be associated with sharply fluctuating air leaks and render stable ventilation impossible despite close vigilance. A cuffed tube is also sometimes preferred in heavily bleeding interventions in the head region or in intraoperative antiseptic irrigation of the buccal and pharyngeal cavities, due to the inadequate sealing efficiency of a cuffless tube. Blood, flushed-out debris and secretions from the throat will otherwise find their way largely unimpeded into the distal airways and can significantly complicate the ventilatory course and the course during and immediately after extubation.
Adapting an adult endotracheal tube for use in children has proven to be surprisingly difficult. One solution to this problem has been provided by Fred Gobel in U.S. Pat. No. 7,849,857 in which specific dimensions are given. These dimensions place the upper point for mounting the balloon to the tube below the level of the vocal cords in order to avoid damage. This solution works quite well. It would provide more flexibility for the medical professional and for manufacturing, however, if there were a balloon that could be mounted such that the upper point of attachment of the balloon to the tube is within the area of the vocal cords when in use, yet still avoid damage to the vocal cords.
What is needed is a balloon that may be mounted to a tracheal tube at a point such that it will be within area occupied by the vocal cords when the tube is in use.